A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Inclusion Criteria:

• Adult males and females age >40 years at the time of the first dose of studymedication;
• Weight >40 and <150 kg;
• Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, orprobable IBM according to the European Neuromuscular Centre (ENMC) IBM 2011 researchdiagnostic criteria (Rose et al., 2013). Documented histopathology results must beavailable prior to Baseline (Day 1) to confirm eligibility;
• Able to arise from a chair (with armrests), with use of their arms but without supportfrom another person or device (e.g., cane, walking stick), at Screening and Baseline (Day 1);
• Able to walk 3 meters, turn around, walk back to the chair, and sit down, with orwithout assistive device. Once arisen from the chair, subject may use any walkingdevice but cannot be supported by another person, furniture, or a wall;

Exclusion Criteria:

• Any other form of myositis or myopathy other than IBM, e.g., metabolic or drug-inducedmyopathy, drug-induced myositis, anti-synthetase syndrome, polymyositis ordermatomyositis, cancer-associated myositis (myositis diagnosed within 3 years, eitherbefore or after), myositis in overlap with another autoimmune disease (e.g., systemiclupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy;
• Any condition, e.g., severe degenerative arthritis with limited range of motion, whichprecludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG), in the Investigator's opinion;.
• Presence of another autoimmune or autoinflammatory disease other than indication understudy, e.g., rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy,inflammatory bowel disease, systemic lupus erythematosus. Subjects with Sjogren'ssyndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlledthyroid disease are permitted;